Dual ProGlide vs ProGlide and Angio-Seal for Femoral Access Hemostasis After Transcatheter Aortic Valve Replacement: A Randomised Comparative Trial.

BACKGROUND

Vascular complications increase morbidity and mortality after transcatheter aortic valve replacements (TAVR), often related to failures in vascular closure devices (VCDs). We intended to compare the dual Perclose ProGlide (PP) strategy and the hybrid combination of PP and Angio-Seal (AS) for femoral access hemostasis after TAVR.

METHODS

A randomised controlled trial with 257 patients comparing dual PP with 1 PP and 1 AS (AS+PP) for vascular closure after transfemoral TAVR was conducted. The primary end point was the composite of TAVR access site-related vascular complications and life-threatening type 2/3 or 1 bleeding according to the Valve Academic Research Consortium 3. Secondary end points included additional VCD use and significant peripheral ischemia related to arteriotomy closure within 1 year. Modified VCD failure, defined as failure to achieve hemostasis within 5 minutes or requiring additional endovascular manoeuvres, was also recorded.

RESULTS

The AS+PP combination yielded lower rates of the primary end point (18.2% vs 29.8%; P = 0.0381), vascular complication (18.2% vs 29.8%; P = 0.0381), additional VCD use (0.8% vs 19.0%; P < 0.0001), and modified VCD failure (9.9% vs 33.1%; P < 0.0001) than the dual PP. Bleeding complication rates were similar between the 2 groups. Three-month follow-up vascular duplex tests showed similar common femoral artery (CFA) diameters and peak systolic velocities (PSVs) between the 2 groups, but those with additional intervention had higher PSVs and smaller CFA diameters than those without.

CONCLUSIONS

Combined PP+AS for large-bore femoral access hemostasis after TAVR promises to be more effective and safer than dual PP in terms of vascular complications. Moreover, additional intervention for vascular complications resulted in smaller CFA diameters.

CLINICAL TRIAL REGISTRATION

NCT05491070.